Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Spinal Cord Injuries Clinical Trial

Official title:

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384172
• Other study ID #: HUM00148746
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Mackenzie Moore, MPH
• Phone: 734-647-8568
• Email: mooremac[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers want to see if nerve stimulation interventions cause a change in vaginal blood flow. The effect of this intervention will be compared between women who have neurogenic (spinal cord injury) or non-neurogenic dysfunction and healthy women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Non-dysfunction participants, no spinal cord injury

Inclusion Criteria:

• Adult (over 18 years old) cis-gender female
• Neurologically stable
• Sexually active at least once per month
• Able to consent and communicate effectively with research team

Exclusion Criteria:

• Male
• Pregnancy or planning to become pregnant during study period
• Sexual dysfunction, per short-form Female Sexual Function Index (FSFI) score below 19
• Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 4
• Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
• Suspected or diagnosed epilepsy
• Active infection or active pressure sores in the perineal region
• Implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator
• Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19. Sexual dysfunction participants, non- spinal cord injury

Inclusion Criteria:

• Adult (over 18 years old) cis-gender female
• Neurologically stable
• Sexually active at least once per month
• Sexual dysfunction, per short-form FSFI score below 19
• Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 3
• Able to understand consent and communicate effectively with research team

Exclusion Criteria:

• Male
• Pregnancy or planning to become pregnant during study period
• Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
• Active infection or active pressure sores in the pelvic region
• Implanted pacemaker or defibrillator
• Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19. Sexual dysfunction participants with spinal cord injury

Inclusion Criteria:

• Adult (over 18 years old) cis-gender women
• Clinically diagnosed spinal cord injury (AIS A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (AIS C) at vertebral level within C4-T10 at least six months prior
• Nominally sexually active, but at minimum interest in sexual pleasure even if fully self-induced
• Sexual dysfunction, per short-form FSFI score below 19
• Able to understand consent and communicate effectively with research team

Exclusion Criteria:

• Male
• Spinal cord injury at or above C5 level (C1-C5) if AIS A or B, or spinal cord injury at or above C3 level (C1-C3) if AIS C
• Spinal cord injury below T10 vertebral level or reflexes not preserved
• Acute worsening in motor or sensory function in the last month
• Suspected or diagnosed epilepsy
• Pregnancy or planning to become pregnant during study period
• Active infection or active pressure sores in the perineal region
• Implanted pacemaker or defibrillator
• Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19.

Related Conditions & MeSH terms

• Female Sexual Dysfunction
• Spinal Cord Injuries

Intervention

Device:
• Tibial e-stim
For tibial nerve stimulation, the two electrodes will be placed just above the medial malleolus and the ipsilateral calcaneus on one leg near the ankle.
• Genital e-stim
For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	International Society for the Study of Women's Sexual Health, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum change in vaginal pulse amplitude (VPA) from the average baseline value	VPA will be measured by a vaginal plethysmography transducer	Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Secondary	Maximum change in heart rate from baseline	A heart rate monitor (e.g. electrocardiogram or pulse oximetry) will be placed on the participant's arm, hand, or chest (as is appropriate per monitor)	Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Secondary	Maximum change in blood pressure from baseline	A blood pressure monitor will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) to monitor off-target autonomic responses.	Test baseline (approximately minute 0) up to Test completion (approximately minute 60)